Complications associated using the reamer-irrigator -aspirator (RIA) system: a systematic review and meta-analysis.

INTRODUCTION: Complications associated with the application of the Reamer-irrigator-Aspirator (RIA) system are described in the literature. However, to date a systematic review and meta-analysis to assess prevalence of complications associated with the use of the RIA system have not been conducted. MATERIALS AND METHODS: The review is registered with PROSPERO (CRD42021269982). MEDLINE, the Web of Science Core Collection, and Embase were searched from the inception to 10 August 2021. The primary objective was to assess complications and blood loss associated with the use of the RIA system. RESULTS: Forty-seven studies involving 1834 procedures performed with the RIA system were finally included. A total of 105 complications were reported, with a pooled estimated overall prevalence of 1.7% with a 95% confidence interval (CI) of 0.40 to 3.60, with cortex perforation being the largest reported complication with a total of 34 incidences. A significant subgroup difference was observed (p = 0.02). In subgroup 1 (bone graft harvesting), complication prevalence was 1.4% (95% CI 0.2-3.4); in subgroup 2 (clearance intramedullary canal) it was 0.7% (95% CI 0.00-6.30) and in subgroup 3 (reaming with RIA system prior to nail fixation) 11.9% (95% CI 1.80-26.40). No statistically significant difference for tibia and femur as RIA system application site was observed (CI 0.69-4.19). In studies reporting blood loss, a mean volume of 803.29 ml, a mean drop of hemoglobin of 3.74 g/dl and a necessity of blood transfusion in 9.72% of the patients were observed. CONCLUSIONS: The systematic review and meta-analysis demonstrate a low overall prevalence rate of complications associated with the RIA system. However, especially the risk of cortical perforation and the frequently reported relevant intraoperative blood loss are complications that should be anticipated in perioperative management and ultimately considered when using the RIA system.

Nonunion After an Open Trimalleolar Ankle Fracture: An Extended Clinical Course and a Novel Approach to Tibio-Talo-Calcaneal Arthrodesis.

Nonunion in the setting of chronic osteomyelitis after severe open ankle fractures is a feared outcome with severe loss in patient quality of life. Tibio-talo-calcaneal arthrodesis is a good salvage treatment option in this difficult patient cohort. We report a case of chronic osteomyelitis with severe destruction of the ankle joint after failed fracture fixation of an open trimalleolar ankle fracture. Fusion was ultimately achieved 5 years later using a novel-staged Masquelet technique with external ring fixator stabilization and bone graft reconstruction including femoral harvested autograft using reamer-irrigator-aspirator. This case shows that infection free arthrodesis of the ankle can be achieved even years after failed treatment. This procedure restored significant quality of life through pain relief and much improved mobility and may be a helpful technique in complex tibio-talo-calcaneal arthrodesis in the setting of chronic osteomyelitis and significant joint destruction.

Comparison of reamer irrigator aspirator (RIA) suspension versus bone marrow aspirate concentrate (BMC) for percutaneous treatment of long bone nonunions-A preclinical canine model.

OBJECTIVE: To compare the bone healing effects of percutaneously delivered bone marrow aspirate concentrate (BMC) versus reamer irrigator aspirator (RIA) suspension in a validated preclinical canine ulnar nonunion model. We hypothesized that BMC would be superior to RIA in inducing bone formation across a nonunion site after percutaneous application. The null hypothesis was that BMC and RIA would be equivalent. METHODS: A bilateral ulnar nonunion model (n= 6; 3 matched pairs) was created. Eight weeks after segmental ulnar ostectomy, RIA from the ipsilateral femur and BMC from the proximal humerus were harvested and percutaneously administered into either the left or right ulnar defect. The same volume (3 ml) of RIA suspension and BMC were applied on each side. Eight weeks after treatment, the dogs were euthanized, and the nonunions were evaluated using radiographic, biomechanical, and histologic assessments. RESULTS: All dogs survived for the intended study duration, formed radiographic nonunions 8 weeks after segmental ulnar ostectomy, and underwent the assigned percutaneous treatment. Radiographic and macroscopic assessments of bone healing at the defect sites revealed superior bridging-callous formation in BMC-treated nonunions. Histologic analyses revealed greater amount of bony bridging and callous formation in the BMC group. Biomechanical testing of the treated nonunions did not reveal any significant differences. CONCLUSION: Bone marrow aspirate concentrate (BMC) had important advantages over Reamer Irrigator Aspirator (RIA) suspension for percutaneous augmentation of bone healing in a validated preclinical canine ulnar nonunion model based on clinically relevant radiographic and histologic measures of bone formation.

Reamer irrigator aspirator (RIA) reduces risk of fat embolism in bilateral pediatric femur shaft fractures: a case report.

A 14-year-old male patient was successfully treated with the reamer irrigator aspirator for femur intramedullary rod preparation after sustaining right and left closed femur fractures because of an all-terrain vehicle accident. In patients already categorized as high risk for fat embolism syndrome, such as those with bilateral femur fractures, reaming both femora greatly increases the likelihood of this complication. The reamer irrigator aspirator provides an effective tool that potentially mitigates the risk of fat embolism syndrome in pediatric patients with this type of orthopedic trauma.

Outcomes of Antibiotic-Impregnated Calcium Sulfate, Reamer-Irrigator-Aspirator, and Locked Intramedullary Static Spacer in the Treatment of Periprosthetic Joint Infection in the Multiply Revised and Infected Knee: A Single-Center Case Series.

Background: Periprosthetic joint infection after total knee arthroplasty is commonly treated via 2-stage revision utilizing either articulating or static antibiotic cement spacers. While recent literature exhibits a slight functional advantage in favor of articulating spacers, those patients with a history of recurrent infection/multiple revision procedures are frequently excluded from these studies. The purpose of this study was to report infection eradication rates and efficacy of utilizing antibiotic-loaded locked intramedullary nail for infection for the multiply revised, infected total knee arthroplasty. Methods: A retrospective review was performed of all consecutive patients receiving static spacers between 2017 and 2020 at an academic medical center. Surgical techniques for all patients included irrigation and debridement using a reamer-irrigator-aspirator, injection of antibiotic-loaded calcium sulfate into the intramedullary canal, and nail placement. Antibiotic-loaded cement is then used to create a spacer block in the joint space. A Cox proportional hazard regression was run to identify risk factors for reinfection. Results: Forty-two knees in 39 patients were identified meeting inclusion criteria. Overall, there was an 68.8% infection eradication rate at an average of 46.9 months following spacer placement. The only risk factors identified on cox regression were increasing number of previous spacers, a surrogate for previous infections (hazards ratio = 14.818, P value = .021), and increasing operative time during spacer placement (hazards ratio = 1.014, P value = .039). Conclusions: Use of static spacers, in conjunction with reamer-irrigator-aspirator and antibiotic-loaded calcium sulfate, can be effective in treating chronic, complex periprosthetic joint infections in the setting of bone loss and or soft-tissue compromise and produced similar results to more simple infection scenarios.

Transfusion after harvesting bone graft with RIA: Practice changes reduced transfusion rate by more than half.

INTRODUCTION: The Reamer Irrigator Aspirator (RIA) is frequently used as a tool for bone graft harvesting procedures. The initial use of this instrument for bone grafting was met with significant blood loss and high transfusion rates. However, the RIA remains an excellent tool to obtain large volumes of viable autologous graft. The aim of this study was to investigate how changes in the technical use of the RIA may affect blood loss. MATERIALS AND METHODS: We conducted a retrospective chart review of all patients who underwent RIA bone graft harvest over a 12-year study period. The patients were divided into two cohorts based upon changes in the technique used to obtain autograft harvest with the RIA. The traditional cohort (2008-2012) connected the RIA to dilation and curettage suction and selected reamer size based on radiographic parameters. The modified cohort (2012-2020) connected the RIA to wall suction, used improved techniques for reamer head sizing, and more diligence was paid toward the time the RIA was suctioning in the canal. Demographic information, surgical details, pre- and post-operative hematocrit (HCT), transfusion rate, intra-operative blood loss, reported volume of graft harvested, and iatrogenic fracture were recorded. RESULTS: 201 patients were included in the study with 61 patients in the traditional and 140 patients in the modified cohorts respectively. The average age was 51 years (range: 18-97) with 107 (53%) males. There was no difference in the demographic data between the two cohorts. No difference was noted between the traditional and modified cohorts in terms of the amount of average graft harvested (54cc vs 51cc; p = 0.34) or major complications (1 vs 2; p = 0.91). However, when comparing the traditional versus modified cohorts the traditional group demonstrated a larger average blood loss (675cc vs 500cc; p=<0.01) and HCT drop (13.7 vs 9.5; p=<0.01) with a higher transfusion rate (44% vs 19%; p = 0.001). CONCLUSION: This series demonstrated a significant improvement in blood loss and transfusion with modified techniques used to obtain autologous bone graft with the RIA. Importantly, these techniques do not appear to limit bone graft harvest yield and can therefore be efficiently implemented without limiting the utility of the RIA.

A case report of membrane induction combined with RIA technique for the repair of distal humerus segmentary bone defect.

Bone nonunion and bone defect are common postoperative complications in clinic. Membrane induction or Ilizarov technique is often used to repair bone defect. Autologous bone is often used for bone defect repair and reconstruction, and the anterior superior iliac spine, posterior superior iliac spine or fibula bone is used as the donor area for bone extraction, but there are problems of donor area complications. In recent years, the development of bone marrow aspiration (RIA) has provided a new alternative way for the source of autogenous bone. We report a 48-year-old female patient with a comminuted supracondylar intercondylar fracture of the left humerus due to a car accident. After 8 months of emergency debridement and suture with Kirschner wire internal fixation, the fracture was found to be unhealed with extensive bone defects. We used membrane induction combined with RIA technology to repair and reconstruct the patients, and found good osteogenesis through late follow-up. In theory, membrane induction technique can realize the reconstruction of large segmental bone defects, but the scope of repair is often limited by the lack of autologous bone source. The emergence and development of RIA technology provides us with a new autologous bone donor area for bone repair and reconstruction surgery. It can provide a large amount of high-quality cancellar bone mud through minimally invasive means. Meanwhile, it can reduce patients' pain, infection, fracture, aesthetics and other problems caused by iliac bone extraction, and shorten patients' bed time. Maximize the preservation of the patient's autologous bone source. For the first time in the world, we reported the combination of membrane induction technology and RIA technology in the treatment of segmental bone defects, providing a new idea for the treatment of bone defects.

Acute toxic shock syndrome associated with intra-operative debridement and instrumentation removal for chronic osteomyelitis: A report of two cases.

Gram-positive organisms are known causative agents in toxic shock syndrome (TSS), an acute disease caused by bacterial exotoxins. During routine instrumentation removal for chronic osteomyelitis, intraoperative debridement, reaming, and irrigation can lead to cell lysis and subsequent dissemination of the bacterium exotoxin, which can result in acute cardiovascular compromise. We present two cases of chronic osteomyelitis in healed long-bone fractures that were treated with deep instrumentation removal and surgical debridement using a reamer-irrigator-aspirator (RIA) system. Both patients had positive Streptococcus agalactiae wound cultures and both developed acute intraoperative hypotension during the reaming/irrigation portion of the procedure. Case 1 experienced cardiac arrest and was resuscitated for several days in the ICU. Case 2 underwent intra-operative hypotension and was resuscitated appropriately. The RIA or standard reaming systems must be used with caution during debridement of osteomyelitis in the presence of known toxin producing bacteria. The risk of iatrogenic spread of infection or extravasation of intramedullary contents is present; a high index of suspicion with any change in vital signs and prompt response can help mitigate the effect of adverse outcomes associated with acute and severe intraoperative hypotension.

Resistant distal femoral nonunion treated with combined nail/plate construct and reamer-irrigator-aspirator technique.

OBJECTIVE: This study was performed to evaluate the effectiveness of intramedullary nailing and a lateral locking plate combined with the reamer-irrigator-aspirator (RIA) bone grafting technique for resistant distal femoral nonunion. METHODS: This retrospective observational study was performed from January 2018 to December 2021 and involved five patients who presented with resistant distal femoral nonunion despite undergoing several surgeries. They were treated with intramedullary nailing and a lateral locking plate combined with the RIA bone grafting technique. Postoperative follow-up was performed to observe the healing time, and functional outcomes were evaluated using the Lower Extremity Functional Scale (LEFS). RESULTS: After the patients had been monitored for a mean of 17.9 months, complete bone healing was observed in every patient (mean healing time of 4.8 months). Postoperative wound failure in an older patient was successfully treated with resuturing and nutritional assistance. At the last follow-up, the mean LEFS score was 71.2/80 and the mean knee flexion was 109 degrees. CONCLUSIONS: Our study demonstrates that combining intramedullary nailing and a lateral locking plate with the RIA bone grafting technique enhances biological properties, provides good structural support, and achieves good union and functional results in the management of resistant nonunion of the distal femur.

Fusion Revision Surgery With Reamer-Irrigator-Aspirator to Harvest Autograft After Spinal Pseudarthrosis.

Background and purpose Spinal pseudarthrosis (SPA) is a common complication after attempted cervical or lumbosacral spinal fusion surgery. Revision surgeries usually necessitate bone graft implementation as an adjunct to hardware revision. Iliac crest bone graft is the gold standard but availability can be limited and usage often leads to persistent postoperative pain at the donor site. There is scant literature regarding the use of reamer-irrigator-aspirator (RIA)-harvested bone graft in lumbar spinal fusion. This is a collaborative study between orthopedic surgery and neurosurgery departments to utilize femur intramedullary autograft harvested using the RIA system as an adjunct graft in SPA revision surgeries. Materials and methods A retrospective review was conducted at a single center between August 2014 and December 2017 of patients aged ≥ 18 years and diagnosed with cervical, thoracic, or lumbar SPA who underwent revision fusion surgery using femur intramedullary autograft harvested using the RIA system. Plain radiographs and CT scans were utilized to confirm successful fusion. Results Eleven patients underwent 12 SPA revision surgeries using the RIA system as a source for bone graft in addition to bone morphogenetic protein 2 (BMP-2) and allograft. The mean amount of graft harvested was 51.3 mL (range: 20-70 mL). Nine patients achieved successful fusion (81.8%). The average time to fusion was 9.1 months. Four patients (36.4%) had postoperative knee pain. Regarding patient position and approach for harvesting, 66.7% (n = 8) of cases were positioned prone and a retrograde approach was utilized in 91.7% (n = 11) of cases. Interpretation This is the first case series in known literature to report the RIA system as a reliably considerable source of autologous bone graft for SPA revision surgeries. It provides a useful adjunct to the known types of bone grafts. Patient positioning and the approach choice for graft harvesting can be adjusted according to the fusion approach and the surgeon's preference.

A technical note: How to extract broken Reamer-Irrigator-Aspirator (RIA) metal intramedullary debris.

The Reamer-Irrigator-Aspirator (RIA-2) system has been established as a safe and reliable device to harvest large amounts of autograft. Nevertheless, hardware complications may occur. Breakage of the reamer head from the drive shaft with intramedullary retention of small metal debris has never been dealt with. The authors provide a technical trick as a bailout in this difficult situation.

Low-Intensity Pulsed Ultrasound Promotes Osteogenic Differentiation of Reamer-Irrigator-Aspirator Graft-Derived Cells in Vitro.

Recently, reamer-irrigator-aspirator (RIA) systems have been increasingly used to harvest autologous bone grafts. RIA graft materials contain bone marrow, which provides a viable source to derive large numbers of mesenchymal stem cells. Low-intensity pulsed ultrasound (LIPUS) significantly accelerates the differentiation of stem cells derived from bone marrow. This in vitro study investigated the effect of LIPUS on the osteogenic activity and differentiation of RIA graft-derived cells. A small amount of RIA graft was obtained from seven patients. After the cells derived from RIA grafts were cultured, they were divided into two groups: the LIPUS and control groups. LIPUS was applied once daily for 20 min (1.5 MHz, pulse duration: 200 µs, pulse repetition rate: 1 kHz, spatial average-temporal average intensity: 30 mW/cm2). Alkaline phosphatase activity (113.4% and 130.1% on days 7 and 14), expression of osteoblast-related genes (ALP, Runx2) and mineralization (135.2% on day 21) of the RIA graft-derived cells were significantly higher in the LIPUS group than in the control group. However, LIPUS did not affect the cell proliferation of RIA graft-derived cells. This study indicates that LIPUS may enhance the healing of non-union and critical bone defects treated by autologous bone grafting using the RIA system.

Safety and efficacy of a novel retrograde route for femoral bone graft harvesting by Reamer-Irrigator-Aspirator: a pilot study on 24 patients.

BACKGROUND: The Reamer-Irrigator-Aspirator system was initially developed to reduce fat embolism and thermic necrosis during reamed intramedullary nail fixation of femoral shaft fractures. Currently, this system is used in extended applications including accessing large volume of autologous bone graft, as alternative for iliac crest harvesting. Antegrade femoral bone graft harvesting using the Reamer-Irrigator-Aspirator system is considered the standard technique. The aim of our study is to evaluate the efficacy (bone graft volume) and the complications (blood loss, postoperative pain, and incidence of iatrogenic fractures) of the Reamer-Irrigator-Aspirator system through the retrograde femoral route in a series of patients with post-traumatic bone defects or nonunions. METHODS: A non-controlled single center retrospective observational cohort study was conducted in a level1 trauma center to evaluate all patients who were treated using the RIA system. Between November 2015 and May 2019, 24 patients (8 women and 16 men; mean age: 41 years [range 27-55 years]) with bone defects or nonunions underwent bone graft harvesting using the Reamer-Irrigator-Aspirator system through retrograde femoral route. Postoperative pain, complications, and bone graft volume were analyzed. Inclusion criteria was patients older than 18 years with a diagnosis of post-traumatic bone defect or associated tibial or femoral nonunion, with minimum 6-months follow, treated using the RIA. We hypothesized that the retrograde route of the RIA system is a safe and efficacious method for bone harvesting. RESULTS: The average volume of collected graft was 45 cc (range 30-60 cc). In 83% of the cases, bone grafting was sufficient, while in 17% it was necessary to add iliac crest bone graft to completely fill the bone defect. A mean drop in postoperative hemoglobin of 4.1 g / dL (range 0.5-6.0 g / dL) was evidenced. In 4 cases (33%), a unit of packed red blood cells was required. Regarding postoperative pain, visual analogue scale after 3 months postoperatively was 1.6 in average. After 6 months, the value has decreased to 0.4. There were no perioperative or postoperative complications at 6-month follow-up. CONCLUSION: In this limited case series, large volumes of bone graft were harvested using the retrograde route of the RIA system and there were no intra-/ postoperative complications observed at 6-month follow-up. Therefore this novel technique appears safe and efficacious. However, it's important to highlight that future prospective controlled studies are necessary to validate the insights from this pilot study.

The Reamer-Irrigator-Aspirator (RIA) System for the treatment of aseptic femoral nonunions: Report of two cases and literature review.

Femoral shaft nonunions are disabling complications of fractures, with relevant socioeconomic and psychological impact. The incidence of femoral shaft nonunions is not negligible, ranging between 1% and 10% after intramedullary nailing, but can exceed 20% in case of subtrochanteric fractures. Treatment options are influenced by pathomechanical, anatomical, and clinical factors. Hypertrophic nonunions are usually treated by enhancing stability of fixation, while atrophic nonunions require additional biological stimulation to achieve bone union. The Reamer-Irrigator-Aspirator (RIA) System® was developed to reduce intramedullary pressure and heat generation during intramedullary reaming, thus preventing thermal necrosis and decreasing the risk of fat embolism. The RIA System allows to provide large volumes of high-quality morselized autologous bone, that has shown high osteogenetic and osteoinductive properties. Therefore, its use has been expanded as a valuable source of autologous bone graft for the treatment of large bone defects of different nature. In this article, we present two cases of complex femoral nonunions treated with the use of the RIA System. A review of the published literature on the treatment of femoral nonunions with RIA was also performed. Core tip: In case of atrophic nonunions, the RIA System can be used to obtain biologically active tissue to enhance bone healing. Despite the absence of high-quality studies focused on femoral nonunions, the efficacy of RIA is well-known and orthopaedic surgeons should be aware of this powerful tool.

Autologous Bone Grafting in Trauma and Orthopaedic Surgery: An Evidence-Based Narrative Review.

Autologous bone grafting is common in trauma and orthopaedic surgery. Both the Reamer Irrigator Aspirator (RIA) and Iliac Crest Bone Graft (ICBG) aim to obtain autologous bone graft. Although the process of harvesting a bone graft is considered simple, complications may occur. This study examined morbidity and pain at the donor site, blood loss, and iatrogenic fractures, comparing RIA and ICBG. The source of the autologous bone graft, the alternative graft sites, and the storage modalities of the harvested bone marrow were also evaluated. In May 2021, PubMed, Embase, Scopus, and Google Scholar were accessed, with no time constraints. RIA may produce greater blood loss, but with less morbidity and complications, making it a potential alternative source of bone grafting.

Autologous bone graft: Is it still the gold standard?

Bone grafting has over 100 years of successful clinical use. Despite the successes of autograft bone transplantation, complications of bone grafting are significant, mostly at the donor site. This article reviews the biology of fracture healing, the properties of bone grafts, and reviews the specific advantages and problems associated with autograft bone. Recent techniques such as the Reamer Irrigator Aspirator are described, which has dramatically reduced complications of bone autograft harvesting.

Intramedullary tissue cultures from the Reamer-Irrigator-Aspirator system for diagnosing fracture-related infection.

Fracture-related infection (FRI) is a serious complication following musculoskeletal trauma. Accurate diagnosis and appropriate treatment depend on retrieving adequate deep tissue biopsies for bacterial culture. The aim of this cohort study was to compare intraoperative tissue cultures obtained by the Reamer-Irrigator-Aspirator system (RIA)-system against standard tissue cultures obtained during the same surgical procedure. All patients had long bone fractures of the lower limbs and were assigned to the FRI or Control group based on the FRI consensus definition. The FRI group consisted of 24 patients with confirmed FRI and the Control group consisted of 21 patients with aseptic nonunion or chronic pain (in the absence of other suggestive/confirmatory criteria). Standard tissue cultures and cultures harvested by the RIA-system showed similar results. In the FRI group, standard tissue cultures and RIA cultures revealed relevant pathogens in 67% and 71% of patients, respectively. Furthermore, in four FRI patients, cultures obtained by the RIA-system revealed additional relevant pathogens that were not found by standard tissue culturing, which contributed to the optimization of the treatment plan. In the Control group, there were no false-positive RIA culture results. As a proof-of-concept, this cohort study showed that the RIA-system could have a role in the diagnosis of FRI as an adjunct to standard tissue cultures. Since scientific evidence on the added value of the RIA-system in the management of FRI is currently limited, further research on this topic is required before its routine application in clinical practice.

Pathologic fracture and hardware failure in Streptococcus anginosus femoral osteomyelitis: Case report.

INTRODUCTION: Pathologic fracture of the femur due to Streptococcus anginosus osteomyelitis has rarely been described. With limited evidence for treating S. anginosus osteomyelitis, the orthopaedic surgeon is presented with a difficult treatment decision at index presentation. Presented here is a case of failed conservative management, diagnostic dilemma, failed hardware stabilization, and definitive surgical treatment resulting in good clinical outcome. CASE PRESENTATION: A 69-year-old male experienced acute right thigh pain, edema, and erythema after dental treatment 17 days prior. He was diagnosed with right femoral diaphyseal osteomyelitis and Brodie's abscess. Blood cultures grew S. anginosus, but all site-specific tissue cultures resulted negative. Initial management consisted of intravenous antibiotic therapy and percutaneous abscess drainage. Months later, the patient sustained a displaced pathologic fracture of the diaphyseal femur and there was concern for neoplasm, but biopsies were negative. Stabilization was attempted with a lateral plate and screws. This hardware catastrophically failed in the setting of an oligotrophic femoral nonunion. Ultimately, the patient was successfully treated with an intramedullary nail coated with antibiotic-impregnated cement. Twelve months later, the patient achieved clinical and radiographic healing with no evidence of relapse of his osteomyelitis. CLINICAL DISCUSSION: Conservative management of S. anginosus femoral osteomyelitis was inadequate and corroborates the existing literature. S. anginosus osteomyelitis and pyomyositis may be most optimally treated aggressively with early surgical intervention. CONCLUSION: Early surgical debridement and stabilization of the compromised bone with an antibiotic coated intramedullary nail following medullary reaming may prevent pathologic fracture, eradicate infection, and achieve predictable outcomes.

Convergence of scaffold-guided bone regeneration and RIA bone grafting for the treatment of a critical-sized bone defect of the femoral shaft.

BACKGROUND: Critical-sized bone defects, mainly from trauma, infection or tumor resection are a challenging condition, often resulting in prolonged, complicated course of treatment. Autografts are considered as the gold standard to replace lost bone. However, limited amount of bone graft volume and donor-site morbidity have established the need for the development of alternative methods such as scaffold-based tissue engineering (TE). The emerging market of additive manufacturing (3D-printing) has markedly influenced the manufacturing of scaffolds out of a variety of biodegradable materials. Particularly medical-grade polycaprolactone and tricalcium phosphate (mPCL-TCP) scaffolds show appropriate biocompatibility and osteoconduction with good biomechanical strength in large preclinical animal models. This case report aims to show first evidence of the feasibility, safety, and efficacy of mPCL-TCP scaffolds applied in a patient with a long bone segmental defect. CASE PRESENTATION: The presented case comprises a 29-year-old patient who has suffered a left-sided II° open femoral shaft fracture. After initial external fixation and subsequent conversion to reamed antegrade femoral nailing, the patient presented with an infection in the area of the formerly open fracture. Multiple revision surgeries followed to eradicate microbial colonization and attempt to achieve bone healing. However, 18 months after the index event, still insufficient diaphyseal bone formation was observed with circumferential bony defect measuring 6 cm at the medial and 11 cm at the lateral aspect of the femur. Therefore, the patient received a patient-specific mPCL-TCP scaffold, fitting the exact anatomical defect and the inserted nail, combined with autologous bone graft (ABG) harvested with the Reamer-Irrigator-Aspirator system (RIA-Synthes®) as well as bone morphogenetic protein-2 (BMP-2). Radiographic follow-up 12 months after implantation of the TE scaffold shows advanced bony fusion and bone formation inside and outside the fully interconnected scaffold architecture. CONCLUSION: This case report shows a promising translation of scaffold-based TE from bench to bedside. Preliminary evidence indicates that the use of medical-grade scaffolds is safe and has the potential to improve bone healing. Further, its synergistic effects when combined with ABG and BMP-2 show the potential of mPCL-TCP scaffolds to support new bone formation in segmental long bone defects.